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90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study

NCT07778953 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-21

No results posted yet for this study

Summary

This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (\<65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective.

All participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg/kg; elderly: 0.30 μg/kg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends.

The primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.

Conditions

Interventions

DRUG

Sufentanil Citrate

Sufentanil citrate administered via peripheral intravenous syringe pump during general anesthesia induction. Fixed weight-based total dose within each age sub-cohort; infusion time varies according to biased-coin up-and-down sequential rules.

Sponsors & Collaborators

  • Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China

    collaborator UNKNOWN

  • Shiyou Wei

    lead OTHER

Principal Investigators

  • Xin Lv · Shanghai Pulmonary Hospital, School of Medicine, Tongji University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-01
Primary Completion
2026-12-25
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778953 on ClinicalTrials.gov